Selinexor plus lenalidomide versus lenalidomide alone as maintenance therapy after autologous haematopoietic stem cell transplantation in newly diagnosed multiple myeloma: Results of the phase 3 ALLG MM23 ( SeaLAND ) trial

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Abstract
Summary: SeaLAND (ALLG MM23, ACTRN12620000291987) was a randomized, open‐label phase III study evaluating low‐dose weekly selinexor (40 mg) plus lenalidomide (selinexor‐R) versus lenalidomide alone (R) as post‐transplant maintenance therapy for newly diagnosed, transplant‐eligible multiple myeloma. A total of 142 patients were enrolled (R = 64; selinexor‐R = 78); the trial closed early for futility. At best response, the complete response (≥CR) rate was numerically, but not significantly, higher with selinexor‐R than R (67% vs. 53%, p = 0.09). At 24 months median follow‐up, progression‐free survival (PFS) was not significantly different between selinexor‐R compared to R (hazard ratio [HR] = 1.22; 95% confidence interval [CI] 0.62–2.41; p = 0.56); 24‐month PFS rates were 73% (95% CI 57%–84%) for R and 70% (95% CI: 56%–81%) for selinexor‐R. The mean relative dose intensity (RDI) of R was lower in the selinexor‐R arm compared to R alone (68% vs. 81%, p = 0.002); the mean RDI of S was 55%. Grade ≥3 adverse events were more frequent with selinexor‐R (85% vs. 45%, p < 0.001). Common severe non‐haematological adverse events included infections (R: 6%, selinexor‐R: 19%, p < 0.01) and gastrointestinal disorders (R: 3%, selinexor‐R: 14%, p < 0.05). Selinexor‐R maintenance did not improve PFS and substantially increased toxicity. Selinexor‐R maintenance cannot be recommended for the general myeloma population; we did not observe a benefit among high‐risk disease.
Funding Information
  • Karyopharm Therapeutics

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